Safety and Pharmacokinetics Study of Healthy Male Adults When Repeatedly Administered Through Intravenous Injection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01606163
First received: May 23, 2012
Last updated: January 1, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the safety and pharmacokinetics of healthy male adults when subjects are repeatedly administered GC1102 (Hepabig_Gene) through intravenous injection.


Condition Intervention Phase
Hepatitis B
Biological: GC1102
Other: JW normal saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-dose, Dose Escalation Study to Assess the Safety and Pharmacokinetics of GC1102 (Hepabig-Gene) in Healthy Male Adults

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • Safety of GC1102 when repeatedly administered by intravenous injection to healthy male adults [ Time Frame: screening, -1d, 1d, 2d, 3d, 4d, 5d, 6d, 7d, 8d, 9d, 14d, 21d, 28d ] [ Designated as safety issue: Yes ]
    • Adverse event
    • Diagnostic examinations
    • Physical examinations
    • Vital signs
    • ECG(electrocardiogram)
    • Check of concomitant drug


Secondary Outcome Measures:
  • Pharmacokinetics of GC1102 when repeatedly administered by intravenous injection to healthy male adults [ Time Frame: 1)1d:predose(0h), 0.5, 1, 2, 5, 9, 14 hours after dose 2) 2d~6d:predose(0h) 3) 7d:predose(0h), 0.5, 1, 2, 5, 9, 14 hours after dose 4) 8d, 9d, 14d, 21d, 28d: 0h ] [ Designated as safety issue: No ]
    • Terminal elimination half-life (t½β)
    • Maximum and Average concentration at steady state(Cmax,ss, Cav,ss,)
    • Area-under the concentration-time curve within a dosing interval at steady state (AUCτ,ss)
    • Clearance (CL)
    • Volume of distribution at steady state (Vd,ss)
    • Mean residence time (MRT)
    • Accumulation Index (AI)


Enrollment: 36
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1
  1. Drug:GC1102
  2. Amount:3ml (30,000IU)
Biological: GC1102
  1. Description: GC1102 IV bolus injection during 10~ 30 seconds.
  2. Amount: group1-3ml, group2-5ml, group3-8ml
  3. Subject number: group1-8, group2-8, group3-8
  4. Administration time: 1day, 2day, 3day, 4day, 5day, 6day, 7day(total: 7 times)
Other Name: Hepabig_Gene
Experimental: group 2
  1. Drug: GC1102
  2. Amount: 5ml(50,000IU)
Biological: GC1102
  1. Description: GC1102 IV bolus injection during 10~ 30 seconds.
  2. Amount: group1-3ml, group2-5ml, group3-8ml
  3. Subject number: group1-8, group2-8, group3-8
  4. Administration time: 1day, 2day, 3day, 4day, 5day, 6day, 7day(total: 7 times)
Other Name: Hepabig_Gene
Experimental: group 3
  1. Drug: GC1102
  2. Amount: 8ml (80,000IU)
Biological: GC1102
  1. Description: GC1102 IV bolus injection during 10~ 30 seconds.
  2. Amount: group1-3ml, group2-5ml, group3-8ml
  3. Subject number: group1-8, group2-8, group3-8
  4. Administration time: 1day, 2day, 3day, 4day, 5day, 6day, 7day(total: 7 times)
Other Name: Hepabig_Gene
Placebo Comparator: group 4
drug: JW normal saline
Other: JW normal saline
  1. Description: Normal saline IV bolus injection through 10~ 30 seconds.

    • Each 3 subjects of this placebo comparator group will match with group 1,2,3 respectively. Placebo comparator subjects in each group will be treated with same condition of each group(group 1, group 2, group 3) except being administered JW normal saline.
  2. Subject number: 9
  3. Administration time: 1day, 2day, 3day, 4day, 5day, 6day, 7day(total: 7 times)
Other Name: saline solution

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Those who are healthy, male adult aged 20 years- 45 years when screened.
  • Those whose body weights are over 45kg when screened, and whose BMI scores are 19kg/㎡-28 kg/㎡.
  • Those whose HBs-Ag, HBc-Ab(IgM), HBc-Ab(IgG), HBV DNA quantitative are all negative when screened.
  • Those whose HBs-Ab(titer) in blood is below 500 IU/L when screened.
  • Those who agree to use double protective contraceptive measures from one days before administration of first investigative drug to last follow-up visit(protective contraceptive measures using more than 2 ways among a male condom, a female condom of sex partner, a spermicide of sex partner, an intrauterine device(IUD) of sex partner, a diaphragm of sex partner and a cervical cap of sex partner), and not to provide sperm.
  • Those who voluntarily decide to follow matters that require attention of this study and give written consent to participate in this clinical trial.
  • Those who can visit the medical center to be monitored, and agree to collect blood during study period.

Exclusion Criteria:

  • Those who have GC1102 anti-body when screened
  • Those who have a clinically meaningful disease or history concerning liver, kidney, alimentary system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatry system, blood tumor system, cardiovascular system.
  • Those who have anaphylaxis of drug allergy including HBIG or who have allergy disease requiring treatment.
  • Those who have immunodeficiency disease now.
  • Those who have an anamnesis of Guillain-Barre syndrome.
  • Hemophiliac patients who have a risk of serious bleeding when getting a shot through intravascular injection or those who are being administered anticoagulants
  • Those who are administered live vaccine parenterally within 120 days from being administered first investigative drug. (ex: measles vaccine, epidemic parotitis vaccine, rubella vaccine, cholera vaccine, chickenpox vaccine)
  • Those who are administered interferon or antiviral agents within 120 days from being administered first investigative drug. (except for topical medication)
  • Those who showed signs of an acute fever(over 38℃) within 72 hours from being administered first investigative drug.
  • Those who showed signs of acute disease within 14 days from being administered first investigative drug.
  • Those who donated whole blood within 60 days or ingredient blood within 30 days from being administered first investigative drug or those who are administered blood transfusion within 30 days from being administered first investigative drug.
  • Those who took other investigative drugs within 60 days from being administered first investigative drug.
  • Those who took herbal medicine within 30 days from being administered first investigative drug or took ethical drug(ETC) within 14 days or took over-the- counter drug(OTC) within 7 days from being administered first investigative drug.(but, Those who meet other conditions can join the clinical trials according to investigator's decision)
  • Those who drink excessively caffeine-contained beverage, excessive alcohol, and who are smokers( caffeine> 5 units/ day, alcohol>21 units/ week, cigarette> 10 pieces) or have a history of alcoholism
  • Those who have a history of drug addiction, or showed positive response of urine-drug screening examination (ex: amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepines, cannabinoid, methadone, etc)
  • Those who showed positive sign of serum test(A-type hepatitis test(HAV IgM Ab), C-type hepatitis test(HCV Ab screening), HIV test(HIV Ag & Ab), Syphilis high quality reagin test.
  • Those whose serum creatinine, ALT, AST, or total bilirubin exceeded the standard 1.5 times by the diagnostic lab test.
  • Those who cannot eat standard meals provided by Seoul Asan medical center.
  • Those who are judged disqualified to join clinical trials by investigator for other causes.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606163

Locations
Korea, Republic of
Department of clinical pharmacology and therapeutics
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Green Cross Corporation
Investigators
Principal Investigator: Kyun-Seop Bae, MD, PhD Department of clinical pharmacology and therapeutics
  More Information

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01606163     History of Changes
Other Study ID Numbers: GC1102
Study First Received: May 23, 2012
Last Updated: January 1, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on April 23, 2014